Duns Number:044611812
Device Description: PowerPort MRI isp, 8F ChronoFlex Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Ki PowerPort MRI isp, 8F ChronoFlex Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit
Catalog Number
1808380
Brand Name
Nautilus Delta Port
Version/Model Number
1808380
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LJT
Product Code Name
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Public Device Record Key
7bdb3e7a-a648-43cb-a57f-351ab939c449
Public Version Date
October 23, 2019
Public Version Number
5
DI Record Publish Date
June 22, 2017
Package DI Number
10801741136754
Quantity per Package
5
Contains DI Package
00801741136757
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3348 |
| U | Unclassified | 8 |